Cabazitaxel for Hormone-Relapsed Metastatic Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology based upon the company's submission to NICE. Clinical evidence for cabazitaxel was derived from a multinational randomised open-label phase III trial (TROPIC) of cabazitaxel plus prednisone or prednisolone compared with mitoxantrone plus prednisone or prednisolone, which was assumed to represent best supportive care. The NICE final scope identified a further three comparators: abiraterone in combination with prednisone or prednisolone; enzalutamide; and radium-223 dichloride for the subgroup of people with bone metastasis only (no visceral metastasis). The company did not consider radium-223 dichloride to be a relevant comparator. Neither abiraterone nor enzalutamide has been directly compared in a trial with cabazitaxel. Instead, clinical evidence was synthesised within a network meta-analysis (NMA). Results from TROPIC showed that cabazitaxel was associated with a statistically significant improvement in both overall survival and progression-free survival compared with mitoxantrone. Results from a random-effects NMA, as conducted by the company and updated by the ERG, indicated that there was no statistically significant difference between the three active treatments for both overall survival and progression-free survival. Utility data were not collected as part of the TROPIC trial, and were instead taken from the company's UK early access programme. Evidence on resource use came from the TROPIC trial, supplemented by both expert clinical opinion and a UK clinical audit. List prices were used for mitoxantrone, abiraterone and enzalutamide as directed by NICE, although commercial in-confidence patient-access schemes (PASs) are in place for abiraterone and enzalutamide. The confidential PAS was used for cabazitaxel. Sequential use of the advanced hormonal therapies (abiraterone and enzalutamide) does not usually occur in clinical practice in the UK. Hence, cabazitaxel could be used within two pathways of care: either when an advanced hormonal therapy was used pre-docetaxel, or when one was used post-docetaxel. The company believed that the former pathway was more likely to represent standard National Health Service (NHS) practice, and so their main comparison was between cabazitaxel and mitoxantrone, with effectiveness data from the TROPIC trial. Results of the company's updated cost-effectiveness analysis estimated a probabilistic incremental cost-effectiveness ratio (ICER) of £45,982 per quality-adjusted life-year (QALY) gained, which the committee considered to be the most plausible value for this comparison. Cabazitaxel was estimated to be both cheaper and more effective than abiraterone. Cabazitaxel was estimated to be cheaper but less effective than enzalutamide, resulting in an ICER of £212,038 per QALY gained for enzalutamide compared with cabazitaxel. The ERG noted that radium-223 is a valid comparator (for the indicated sub-group), and that it may be used in either of the two care pathways. Hence, its exclusion leads to uncertainty in the cost-effectiveness results. In addition, the company assumed that there would be no drug wastage when cabazitaxel was used, with cost-effectiveness results being sensitive to this assumption: modelling drug wastage increased the ICER comparing cabazitaxel with mitoxantrone to over £55,000 per QALY gained. The ERG updated the company's NMA and used a random effects model to perform a fully incremental analysis between cabazitaxel, abiraterone, enzalutamide and best supportive care using PASs for abiraterone and enzalutamide. Results showed that both cabazitaxel and abiraterone were extendedly dominated by the combination of best supportive care and enzalutamide. Preliminary guidance from the committee, which included wastage of cabazitaxel, did not recommend its use. In response, the company provided both a further discount to the confidential PAS for cabazitaxel and confirmation from NHS England that it is appropriate to supply and purchase cabazitaxel in pre-prepared intravenous-infusion bags, which would remove the cost of drug wastage. As a result, the committee recommended use of cabazitaxel as a treatment option in people with an Eastern Cooperative Oncology Group performance status of 0 or 1 whose disease had progressed during or after treatment with at least 225 mg/m(2) of docetaxel, as long as it was provided at the discount agreed in the PAS and purchased in either pre-prepared intravenous-infusion bags or in vials at a reduced price to reflect the average per-patient drug wastage.

CERVIXCHECK: A SPIRITUALLY-BASED SMS TEXT MESSAGING PILOT INTERVENTION TO INCREASE CERVICAL CANCER AWARENESS AND PAP TEST SCREENING INTENTION AMONG AFRICAN AMERICAN WOMEN

African American women account for a disproportionate burden of cervical cancer incidence and mortality rate when compared to non-Hispanic White women. Cervical cancer is one of the most preventable types of cancer, and women can be screened for it with a routine Pap test. Given that religion occupies an essential place in African American lives, framing health messages with important spiritual themes and delivering them through a popular communication delivery channel may allow for a more culturally-relevant and accessible technology-based approach to promoting cervical cancer educational content to African American women. Using community-engaged research as a framework, the purpose of this multiple methods study was to develop, pilot test, and evaluate the feasibility, acceptability, and initial efficacy of a spiritually-based SMS text messaging intervention to increase cervical cancer awareness and Pap test screening intention among African American women. The study recruited church-attending African American women ages 21-65 and was conducted in three phases. Phases 1 and 2 consisted of a series of focus group discussions (n=15), cognitive response interviews (n=8), and initial usability testing that were conducted to inform the intervention development and modifications. Phase 3 utilized a non-experimental one-group pretest-posttest design to pilot test the 16-day text messaging intervention (n=52). Of the individuals enrolled, forty-six completed the posttest (retention rate=88%). Findings provided evidence for the early feasibility, high acceptability, and some initial efficacy of the CervixCheck intervention. There were significant pre-post increases observed for knowledge about cervical cancer and the Pap test (p = .001) and subjective norms (p = .006). Additionally, results post-intervention revealed that 83% of participants reported being either “satisfied” or “very satisfied” with the program and 85% found the text messages either “useful” or “very useful”. 85% of the participants also indicated that they would “likely” or “very likely” share the information they learned from the intervention with the women around them, with 39% indicating that they had already shared some of the information they received with others they knew. A spiritually-based SMS text messaging intervention could be a culturally appropriate and cost-effective method of promoting cervical cancer early detection information to African American women.

Platform technology towards the chemical fingerprinting methamphetamine from ephedrine pathways.

A platform technology based on two-dimensional chromatography that allows for the chemical fingerprinting of the synthetic routes of methamphetamine manufacture has been developed. Further novel clandestine synthetic chemistry pathways to methamphetamine have been investigated in collaboration with the Victoria Police Forensic Services Department.

The judicious utilization of new technologies through authentic learning in higher education : a case study

Though technology holds significant promise for enhanced teaching and learning it is unlikely to meet this promise without a principled approach to course design. There is burgeoning discourse about the use of technological tools and models in higher education, but much of the discussion is fixed upon distance learning or technology based courses. This paper will develop and propose a balanced model for effective teaching and learning for “on campus” higher education, with particular emphasis on the opportunities for revitalisation available through the judicious utilisation of new technologies. It will explore the opportunities available for the creation of more authentic learning environments through the principled design. Finally it will demonstrate with a case study how these have come together enabling the creation of an effective and authentic learning environment for one pre-service teacher education course at the University of Queensland.

More than experiential learning or volunteering : a case study of community service learning within the Australian context

Community service learning is the integration of experiential learning and community service into coursework such that community needs are met and students gain both professional skills and a sense of civic responsibility. A critical component is student reflection. This paper provides an example of the application of community service learning within an undergraduate health unit at the Queensland University of Technology. Based on survey data from 36 program participants, it demonstrates the impact of CSL on student outcomes. Results show that students benefited by developing autonomy through real world experiences, through increased self-assurance and achievement of personal growth, through gaining new insights into the operations of community service organisations and through moving towards becoming responsible citizens. Students expect their CSL experience to have long-lasting impact on their lives, with two-thirds of participants noting that they would like to continue volunteering as part of their future development.

A study and comparison of multimedia Web searching : 1997-2006

Searching for multimedia is an important activity for users of Web search engines. Studying user's interactions with Web search engine multimedia buttons, including image, audio, and video, is important for the development of multimedia Web search systems. This article provides results from a Weblog analysis study of multimedia Web searching by Dogpile users in 2006. The study analyzes the (a) duration, size, and structure of Web search queries and sessions; (b) user demographics; (c) most popular multimedia Web searching terms; and (d) use of advanced Web search techniques including Boolean and natural language. The current study findings are compared with results from previous multimedia Web searching studies. The key findings are: (a) Since 1997, image search consistently is the dominant media type searched followed by audio and video; (b) multimedia search duration is still short (>50% of searching episodes are <1 min), using few search terms; (c) many multimedia searches are for information about people, especially in audio search; and (d) multimedia search has begun to shift from entertainment to other categories such as medical, sports, and technology (based on the most repeated terms). Implications for design of Web multimedia search engines are discussed.

Image acquisition and manipulation protocols for CT-PET fusion to improve the accuracy of gross tumour volume localisation for 3D conformal radiotherapy for lung cancer

Aims: To develop clinical protocols for acquiring PET images, performing CT-PET registration and tumour volume definition based on the PET image data, for radiotherapy for lung cancer patients and then to test these protocols with respect to levels of accuracy and reproducibility. Method: A phantom-based quality assurance study of the processes associated with using registered CT and PET scans for tumour volume definition was conducted to: (1) investigate image acquisition and manipulation techniques for registering and contouring CT and PET images in a radiotherapy treatment planning system, and (2) determine technology-based errors in the registration and contouring processes. The outcomes of the phantom image based quality assurance study were used to determine clinical protocols. Protocols were developed for (1) acquiring patient PET image data for incorporation into the 3DCRT process, particularly for ensuring that the patient is positioned in their treatment position; (2) CT-PET image registration techniques and (3) GTV definition using the PET image data. The developed clinical protocols were tested using retrospective clinical trials to assess levels of inter-user variability which may be attributed to the use of these protocols. A Siemens Somatom Open Sensation 20 slice CT scanner and a Philips Allegro stand-alone PET scanner were used to acquire the images for this research. The Philips Pinnacle3 treatment planning system was used to perform the image registration and contouring of the CT and PET images. Results: Both the attenuation-corrected and transmission images obtained from standard whole-body PET staging clinical scanning protocols were acquired and imported into the treatment planning system for the phantom-based quality assurance study. Protocols for manipulating the PET images in the treatment planning system, particularly for quantifying uptake in volumes of interest and window levels for accurate geometric visualisation were determined. The automatic registration algorithms were found to have sub-voxel levels of accuracy, with transmission scan-based CT-PET registration more accurate than emission scan-based registration of the phantom images. Respiration induced image artifacts were not found to influence registration accuracy while inadequate pre-registration over-lap of the CT and PET images was found to result in large registration errors. A threshold value based on a percentage of the maximum uptake within a volume of interest was found to accurately contour the different features of the phantom despite the lower spatial resolution of the PET images. Appropriate selection of the threshold value is dependant on target-to-background ratios and the presence of respiratory motion. The results from the phantom-based study were used to design, implement and test clinical CT-PET fusion protocols. The patient PET image acquisition protocols enabled patients to be successfully identified and positioned in their radiotherapy treatment position during the acquisition of their whole-body PET staging scan. While automatic registration techniques were found to reduce inter-user variation compared to manual techniques, there was no significant difference in the registration outcomes for transmission or emission scan-based registration of the patient images, using the protocol. Tumour volumes contoured on registered patient CT-PET images using the tested threshold values and viewing windows determined from the phantom study, demonstrated less inter-user variation for the primary tumour volume contours than those contoured using only the patient’s planning CT scans. Conclusions: The developed clinical protocols allow a patient’s whole-body PET staging scan to be incorporated, manipulated and quantified in the treatment planning process to improve the accuracy of gross tumour volume localisation in 3D conformal radiotherapy for lung cancer. Image registration protocols which factor in potential software-based errors combined with adequate user training are recommended to increase the accuracy and reproducibility of registration outcomes. A semi-automated adaptive threshold contouring technique incorporating a PET windowing protocol, accurately defines the geometric edge of a tumour volume using PET image data from a stand alone PET scanner, including 4D target volumes.

Profiling HRM in innovative firms

Effective people management is essential to successful innovation, however no single human resource function or practice can facilitate the development of innovation capacity in an organization. Several studies have argued that different bundles or configurations of human resource practices can improve innovation performance, but there is little empirically based research that provides details of the practices utilized by different types of innovative firms. In this exploratory, qualitative study of innovative Danish firms we examine the profiles of human resource practices evident in a sample of firms recognized for their innovative performance. In examining these profiles, we analyze how characteristics of the organizations, namely their size and the nature of industry specific core capabilities, influence the human resource practices used to support innovation. Our initial findings indicate that in this sample of firms size is not a factor but knowledge-intensive firms have notably different profiles of human resource practices to technology-based firms.

Enhancing the use of Internet and Web services for quality learning : an action research

Internet and Web services have been used in both teaching and learning and are gaining popularity in today’s world. E-Learning is becoming popular and considered the latest advance in technology based learning. Despite the potential advantages for learning in a small country like Bhutan, there is lack of eServices at the Paro College of Education. This study investigated students’ attitudes towards online communities and frequency of access to the Internet, and how students locate and use different sources of information in their project tasks. Since improvement was at the heart of this research, an action research approach was used. Based on the idea of purposeful sampling, a semi-structured interview and observations were used as data collection instruments. 10 randomly selected students (5 girls and 5 boys) participated in this research as the controlled group. The study findings indicated that there is a lack of educational information technology services, such as e-learning at the college. Internet connection being very slow was the main barrier to learning using e-learning or accessing Internet resources. There is a strong relationship between the quality of written task and the source of the information, and between Web searching and learning. The source of information used in assignments and project work is limited to books in the library which are often outdated and of poor quality. Project tasks submitted by most of the students were of poor quality.

Robust suspicious behaviour detection for smart surveillance systems

Video surveillance technology, based on Closed Circuit Television (CCTV) cameras, is one of the fastest growing markets in the field of security technologies. However, the existing video surveillance systems are still not at a stage where they can be used for crime prevention. The systems rely heavily on human observers and are therefore limited by factors such as fatigue and monitoring capabilities over long periods of time. To overcome this limitation, it is necessary to have “intelligent” processes which are able to highlight the salient data and filter out normal conditions that do not pose a threat to security. In order to create such intelligent systems, an understanding of human behaviour, specifically, suspicious behaviour is required. One of the challenges in achieving this is that human behaviour can only be understood correctly in the context in which it appears. Although context has been exploited in the general computer vision domain, it has not been widely used in the automatic suspicious behaviour detection domain. So, it is essential that context has to be formulated, stored and used by the system in order to understand human behaviour. Finally, since surveillance systems could be modeled as largescale data stream systems, it is difficult to have a complete knowledge base. In this case, the systems need to not only continuously update their knowledge but also be able to retrieve the extracted information which is related to the given context. To address these issues, a context-based approach for detecting suspicious behaviour is proposed. In this approach, contextual information is exploited in order to make a better detection. The proposed approach utilises a data stream clustering algorithm in order to discover the behaviour classes and their frequency of occurrences from the incoming behaviour instances. Contextual information is then used in addition to the above information to detect suspicious behaviour. The proposed approach is able to detect observed, unobserved and contextual suspicious behaviour. Two case studies using video feeds taken from CAVIAR dataset and Z-block building, Queensland University of Technology are presented in order to test the proposed approach. From these experiments, it is shown that by using information about context, the proposed system is able to make a more accurate detection, especially those behaviours which are only suspicious in some contexts while being normal in the others. Moreover, this information give critical feedback to the system designers to refine the system. Finally, the proposed modified Clustream algorithm enables the system to both continuously update the system’s knowledge and to effectively retrieve the information learned in a given context. The outcomes from this research are: (a) A context-based framework for automatic detecting suspicious behaviour which can be used by an intelligent video surveillance in making decisions; (b) A modified Clustream data stream clustering algorithm which continuously updates the system knowledge and is able to retrieve contextually related information effectively; and (c) An update-describe approach which extends the capability of the existing human local motion features called interest points based features to the data stream environment.

Participatory innovation to develop traditional Indonesian craft industries

This paper presents a participatory project involving the traditional glass bead craft industries in rural Java, Indonesia. Their survival is in danger due to tight business competition among themselves and due to shortcomings in existing business mechanisms. The research explores a departure from traditional government assistance programs which seek to train craftspeople with new kinds of technology based skills. Instead, the project explores alternate business mechanisms, ways for traditional craftspeople to get more power in business mechanisms, and ways to develop new design strategies through a collaborative approach. The ultimate goal is to ensure sustainable livelihoods for traditional craft producers and for the traditional craft industry in general. This research also aims to support the economic strength and competitiveness of these industries indirectly by i. Generating knowledge about developing innovation strategies in the traditional craft industry; ii. Providing an alternative advisory program to support the sustainability of the traditional souvenir craft industry; iii. Providing inputs for designers or any institutions who intend to establish collaborative design learning with craft industries. Understanding the situation carefully,including sensitivities such as culture and tensions among people, building self-confidence and trust among craftspeople as well as involving junior designers are keys in pursuing a participatory project in this case.

Using game technologies to improve the safety of construction plant operations

Many accidents occur world-wide in the use of construction plant and equipment, and safety training is considered by many to be one of the best approaches to their prevention. However, current safety training methods/tools are unable to provide trainees with the hands-on practice needed. Game technology-based safety training platforms have the potential to overcome this problem in a virtual environment. One such platform is described in this paper - its characteristics are analysed and its possible contribution to safety training identified. This is developed and tested by means of a case study involving three major pieces of construction plant, which successfully demonstrates that the platform can improve the process and performance of the safety training involved in their operation. This research not only presents a new and useful solution to the safety training of construction operations, but illustrates the potential use of advanced technologies in solving construction industry problems in general.

Third international workshop on empirical research in business process management (ER-BPM 2012)

Empirical research in business process management(BPM) is coming of age. In 2009, when the inaugural ER-BPM workshop was held, the field of BPM research was characterized by a strong emphasis on solution development, but also by an increasing demand for insights or evaluations of BPM technology based on dedicated empirical research strategies. The ER-BPM workshop series was created to provide an international forum for researchers to discuss and present such research.

Background to the development of a curriculum for the history of “cyber” and “communications” security

For any discipline to be regarded as a professional undertaking by which its members may be treated as true “professionals” in a specific area, practitioners must clearly understand that discipline’s history as well as the place and significance of that history in current practice as well as its relevance to available technologies and artefacts at the time. This is common for many professional disciplines such as medicine, pharmacy, engineering, law and so on but not yet, this paper submits, in information technology. Based on twenty five elapsed years of experience in developing and delivering Cybersecurity courses at undergraduate and postgraduate levels, this paper proposes a rationale and set of differing perspectives for the planning and development of curricula relevant to the delivery of appropriate courses in the history of cybersecurity or information assurance to information and communications technology (ICT) students and thus to potential information technology professionals.

Consumer acceptance of m-wellbeing services : a social marketing perspective

Purpose This study aims to employ the Model of Goal-Directed Behaviour (MGB) to examine the consumer acceptance of technology-based self-service (TBSS) for a credence service instrumental to a social goal. Credence services are increasingly delivered via self-service technology and in social marketing, the achievement of social goals can be contingent on consumer acceptance of these services. However, little is known about the determinants of acceptance and extant marketing literature fails to account for emotional and goal influences which are likely to be important. Design/methodology/approach The authors interviewed 30 young adults with self-reported stress, anxiety or depression as potential users of a self-help mental health service delivered via mobile phone. The data were analysed deductively and inductively with the assistance of NVivo. Findings The findings generally support using the MGB to enhance understanding of consumers' acceptance of TBSS. The paper also found evidence of the importance of maintenance self-efficacy, the self-evaluation of the ability to continue using the service, and a previously ignored element of consumer level competition that arises between alternatives that achieve the same goal. Originality/value This study is the first to examine factors that influence consumers' acceptance of TBSS for credence services aimed at achieving a social goal. It builds on understanding of consumer decision making in social marketing, particularly the influence of self-efficacy and competition. It also contributes to attitudinal research by providing initial evidence for deepening and broadening the MGB in the context of TBSSs.